ES2816076T3 - Curved ultrasound surgical device and manufacturing method - Google Patents

Abstract

An ultrasound surgical device (10, 110) comprising: an elongated waveguide (12, 112) having a longitudinal axis (L, L8, L9) and a distal end; the ultrasound surgical device (10) further comprising: a blade (24, 124, 224, 324, 424, 524, 624, 824) extending away from the distal end of the waveguide (12, 112), said blade (24, 124, 224, 324, 424, 524, 624, 824) a length, a distal end, and a curved portion that includes at least five faces extending longitudinally along at least a portion of the length of the blade (24, 124, 224, 324, 424, 524, 624, 824), each of said faces having a width that extends perpendicular to the longitudinal axis (L, L8, L9) of the waveguide ( 12, 112) and a length extending orthogonal to said width, wherein each of the faces is flat across its width and is either flat along its entire length or includes one or more curved segments (28A, 28C, 34A, 34C) along its length, each of the curved segments (28A, 28C, 34A, 34C) being curved on an individual face dual curved in the same direction, in such a way that the curvature axes of each of the curved segments (28A, 28C, 34A, 34C) of an individual face are parallel to each other, and the curvature axis of each of the curved segments (28A, 28C, 34A, 34C) of the blade faces (24, 124, 224, 324, 424, 524, 624, 824) is perpendicular to a plane that includes the longitudinal axis (L, L8, L9 ) of the waveguide (12, 112); and furthermore wherein at least one of the faces of the blade (24, 124, 224, 324, 424, 524, 624, 824) includes one of said curved segments (28A, 28C, 34A, 34C).

Description

DESCRIPTION

Curved ultrasound surgical device and manufacturing method

Background

Ultrasound-actuated surgical blades have long been used for cutting, coagulation, and / or dissection of tissue during various medical procedures. Compared to conventional static scalpels, for example, ultrasound-actuated blades typically require less force to cut tissue, and can also provide blood vessel coagulation (particularly when the device includes a blade-associated jaw member).

Ultrasound surgical blades are typically provided at the end of an elongated waveguide, which in turn is operatively coupled to an ultrasound transducer. The transducer, which is often provided as part of or housed within a handle, is adapted to convert electrical energy (typically supplied by an external generator) into vibratory motion, typically longitudinal vibrations, at an ultrasound frequency. In many cases, the transducer includes a "Langevin stack" of piezoelectric discs for this purpose. The standing wave produced by the transducer is transmitted from the transducer to the waveguide, and propagates the length of the waveguide to the blade at the distal end of the waveguide. As a result, the blade vibrates at an ultrasound frequency.

When the ultrasonically vibrating blade is driven against tissue, such as by manipulating a handle and / or clamping tissue between the blade and a jaw member, the vibratory mechanical energy of the blade is transmitted to tissue, not just cutting the tissue but also generating frictional heat and causing cavitation, coaptation and coagulation of the tissue.

In some cases, the blade is straight and, when used with a longitudinally vibrating transducer, it vibrates only in the longitudinal direction (parallel to the longitudinal axis of the waveguide). However, it is often desirable to provide ultrasonically actuated blades that curve in one or more directions. Curved blades provide a variety of benefits, including greater access to certain locations within a patient, as well as improved visibility during use. While curved blades, when operatively connected to a transducer that vibrates longitudinally (for example, via an elongated waveguide), they will generally vibrate in at least one non-longitudinal direction (for example, longitudinally). transverse) due to the asymmetric nature of the curved blade with respect to the longitudinal axis of the waveguide, such non-longitudinal vibrations in the blade during use can be advantageous. For example, some curved blades that vibrate in at least one non-longitudinal direction can provide greater blade travel, particularly at the distal end of the blade.

Curved blades, however, can be difficult to manufacture. For example, curved knives of the prior art often have one or more faces (i.e. surfaces) that curve in two or more directions, thus requiring the use of specialized equipment such as angled chamfer finishing mills ( also referred to as milling machines), multiple types of end mills, and precise control of the depth of cut (Z-axis) of the milling machine to obtain precise blade geometry (ie "end effector"). While simpler square cross section blades are easier to manufacture, allowing for less complex machining processes, these blades do not provide the benefits of a curved blade geometry.

US 2007198005 A1 proposes a coagulation cutter. More especially, a coagulation cutter comprises: a transmitting element for transmitting energy, for treating living body tissue, to living body tissue; an outer sheath through which the transmitter element is passed; and a gripping section supported on the end tip portion of the outer sheath so as to be able to rotate with respect to the transmitter element, which allows the living tissue of the body to be grasped against the transmitter element. With such an arrangement, after rotating the gripping section towards the transmitting element to be in a closed state, the faces of the transmitting element and the gripping section, which are facing each other, provide a contact part, where the transmitter element and the grip section are in contact with each other over a predetermined length, to make an incision in the living tissue of the grasped body between the transmitter element and the grip section, and a non-contact part, where the transmitter element and the gripping section are provided with a predetermined interval on both sides of the axis extending in the direction of the predetermined length of the contact part so that they are not in contact with each other, to coagulate the living tissue of the body.

While a variety of devices and techniques may exist for providing curved ultrasound actuated blades, it is believed that no one prior to the inventor has made or used an invention as described herein.

Brief description of the drawings

While the specification concludes with claims that specifically point out and clearly claim the invention, it is believed that the invention will be better understood from the detailed description of certain embodiments thereof when read in conjunction with the accompanying drawings. Unless the context indicates otherwise, The same numbers are used in the drawings to identify similar items in the drawings. Also, some of the figures may have been simplified by omitting certain elements to show other elements more clearly. Such omissions are not necessarily indicative of the presence or absence of particular elements in any of the example embodiments, unless explicitly indicated in the corresponding detailed description.

FIG. 1 depicts a partial cross-sectional view of an embodiment of an ultrasound surgical device having a curved blade.

FIG. 2 depicts an embodiment of an ultrasound generator and attached transducer with which the ultrasound surgical device of FIG. 1.

FIG. 3A depicts a schematic side view of an ultrasound shear device.

FIG. 3B depicts a partial cross-sectional view of the ultrasound shear device of FIG. 3A.

FIG. 4A depicts a perspective view of the blade portion of the ultrasound surgical device of FIG. 1.

FIGS. 4B-4E depict side views of the blade of Fig. 4A, with each successive view rotated counterclockwise (as viewed from the distal end of the blade) from the front view.

FIG. 5 represents an enlarged view similar to FIG. 4B.

FIGS. 6A-6E depict views similar to FIGs. 4A-4E of an alternate embodiment of a blade, with each successive view rotated clockwise (as viewed from the distal end of the blade) from the anterior view.

FIG. 7 depicts a perspective view of yet another embodiment of a blade.

FIGS. 8A-8D, 9A-9E, 10A-10E, 11A-11E, 12A-12F, and 13A-13B represent a method of manufacturing the blade of FIG. 5.

FIG. 14 depicts a side view of another alternative embodiment of a blade.

FIG. 15 depicts a perspective view of yet another embodiment of a blade.

FIGS. 16 and 17 represent the front perspective and side views of the distal portion of the ultrasound shear device of FIGS. 3A and 3B, with FIG. 17 depicting the jaw element in its fully closed position against the blade.

FIGS. 18 and 19 represent perspective views, and partially cutaway perspective views of another alternative blade.

FIG. 20 is a schematic illustration of a blade having an upturned face, wherein the radius of curvature of that face changes continuously along that face.

FIGS. 21-25 depict views similar to FIGS. 6B-6E of another alternate embodiment of a blade, with each successive view rotated counterclockwise (as viewed from the distal end of the blade) from the anterior view.

The drawings are intended to illustrate, rather than limit, the scope of the present invention. The embodiments of the present invention may be carried out in ways not necessarily represented in the drawings. Therefore, the drawings are simply intended to aid in the explanation of the invention. Therefore, the present invention is not limited to the precise arrangements shown in the drawings.

Detailed description

Examples of embodiments of the invention are described in the following detailed description for the sole purpose of enabling one of ordinary skill in the art to make and use the invention. Thus, the detailed description and illustration of these embodiments are purely illustrative in nature and are not intended in any way to limit the scope of the invention or its protection. It should also be understood that the drawings are not to scale and in certain cases details that are not necessary for an understanding of the present invention have been omitted.

The embodiments of the present description provide an ultrasound surgical device for use with an ultrasound transducer for medical purposes, as claimed in claims 1 or 23. Preferred embodiments of these devices are claimed in claims 2- 21 and 24.

The blades described herein have a curved portion that includes at least five faces extending longitudinally along at least a portion of the blade, at least one of those faces includes one or more curved segments such that the blade has at least one curved surface along with multiple edges blade suitable for cutting tissue. Each of the faces of the blade is flat across its width, where that width extends perpendicular to the protruding longitudinal axis of the waveguide. The curved segments of an individual face are all curved in a single direction, although that curvature can be positive and / or negative on a single face. The curved blade is provided at the distal end of a waveguide, and the waveguide is adapted for operative coupling (directly or indirectly) to an ultrasound transducer. In some cases, a jaw member is operatively positioned adjacent the curved blade for selective engagement with a face and / or edge of the blade so as to provide both coagulation and cutting, thereby providing a surgical forceps arrangement. (also known as ultrasound shears). With or without an associated jaw element, the cutting blade can be used to cut, coagulate and / or dissect tissue by ultrasound. The term "curved segment" will also be understood to encompass a face that has a single curved segment that extends the entire length of that face (for example, the length of the curved segment is 100% of the face ).

The curved blade embodiments described herein are configured in such a way as to simplify manufacture, while still providing a number of blade edges suitable for cutting tissue. By providing multiple blade edges, the embodiments described herein allow surgeons to employ a greater range of techniques and effects. In addition, the curved blade embodiments described herein also allow tissue to be cut in more than one direction, often without the surgeon having to reposition the device.

FIG. 1 is a partial cross-sectional view of an embodiment of an ultrasound surgical device (10) comprising an elongated waveguide (12) and a curved blade (24). In the particular embodiment shown, the ultrasound surgical device (10) also includes a sheath assembly comprising a hollow cylindrical sheath (60) and a sheath coupler (70) at the proximal end of the sheath (60). In other embodiments, the sheath assembly is omitted.

In the embodiment shown in FIG. 1, the waveguide (12) is located within the sheath (60) and the sheath coupler (70). However, the sheath assembly is not attached directly to the waveguide (12). Instead, and as detailed below, the waveguide (12) can be operatively attached at its proximal end to an ultrasound transducer, and the sheath coupler (70) is attached to the transducer housing. It will be understood, however, that the waveguide (12) may be attached to the sheath assembly (i.e., sheath (60) and / or sheath coupler (70)), such as by welding, adhesive bonding. or in other ways known in the art.

The waveguide (12) includes an internally threaded connector portion (14) at its proximal end, as well as several planes (16) arranged around the circumference of the waveguide (12) adjacent to the connector portion ( 14). The flats (16) provide a nut integral with the waveguide (12) for use in tightening the waveguide onto a transducer, as explained below. While the waveguide (12) is represented as being of unitary construction, in alternative embodiments the waveguide (12) comprises two or more parts joined together (for example, by means of a threaded joint). For example, in an alternative embodiment, the connector portion (14) and the planes (16) comprise a unitary structure that is threadedly attached to the proximal end of the waveguide (12) (for example, by the use of an internally threaded hole and a coupling threaded bolt connecting the two parts of the waveguide (12)). Similarly, although the blade (24) is depicted as an integral part of the waveguide (12), in alternative embodiments the blade (24) is a separate structure that is attached to the distal end of the waveguide ( 12), such as by means of a threaded joint.

FIG. 2 illustrates an example generator (80) and ultrasound transducer (82) with which the ultrasound surgical device (10) can be used. It will be understood that the generator (80) and the transducer (82) are merely exemplary, as the ultrasound surgical device (10) can be used with any of a variety of generators and transducers. The transducer (82) includes a housing (84) that is configured to facilitate grasping and manipulation of the transducer housing (84) by a physician. The proximal end of the housing (84) includes an electrical connector (for example, a plug or socket) for operative connection to the generator (80) via a mating connector (81) provided at the end of a cable similarly connected to generator (80). Therefore, an electrical drive signal comprising an alternating current of ultrasound frequency is supplied from the generator (80) to the transducer (82) via the cable and the connector (81). The transducer (82) converts the drive signal into a stationary ultrasonic vibratory wave at the transducer, which includes the distal portion (85) of the transducer's horn (or speed transformer, not shown) protruding from the distal end of the transducer. casing (84). The transducer housing (84) also includes a threaded boss (89) at its distal end, adjacent to the distal portion (85) of the transducer tube.

A threaded mounting bolt (88) is attached to the distal portion (85) of the transducer tube, such as by tapping and adhesively securing it within a threaded hole (not shown) in the distal portion (85). Therefore, the threaded bolt (88) extends distally from the wall of the distal end (86) of the distal portion (85). It should also be noted that the distal end wall (86) of the distal portion (85) of the transducer tube is located at an antinode to the standing vibratory wave produced by the transducer (82). By way of example, the generator (80) and the transducer (82) in the depicted embodiment are configured to generate a standing vibratory wave having a frequency of approximately 55 kHz. However, various other ultrasound frequencies can be employed, for example, between about 20 and about 120 kHz.

The ultrasound surgical device (10) can be operatively coupled to the transducer (82) in a variety of ways. In the embodiment shown, the connector portion (14) at the proximal end of the waveguide (12) includes a threaded hole (17) that extends inwardly (i.e. distally) from the end wall. proximal (15) of the connector part (14). The threaded hole (17) is sized and configured to threadably receive the mounting bolt (88) of the transducer (82) therein to operatively couple the waveguide (12) to the transducer (82). When the connector portion (14) is threaded onto the mounting bolt (88) of the transducer (82), the proximal end wall (15) of the connector portion (14) abuts the distal end wall (86 ) of the distal portion (85) of the transducer (82). When coupled in this way, the standing vibratory wave produced in the transducer propagates along the length of the waveguide (12). The flats (16) are used to further tighten the waveguide (12) at the distal end of the transducer (82), and a torque wrench (not shown) can be used to ensure that the waveguide is not overtightened. .

As mentioned above, the sheath assembly comprises the cylindrical sheath (60) and the sheath coupler (70), which are attached to each other as shown. The sheath (60) can be attached to the sheath coupler (70) in a variety of ways, such as by welding, adhesive, and / or stamping. In the example embodiment shown in FIG. 1, a proximal portion (61) of the sheath (60) is secured within a conveniently configured cavity within the coupler (70), adjacent the distal end of the coupler. Furthermore, the inside diameter of the proximal part (61) of the sheath (60) is larger than the inside diameter of the part of the sheath (60) external to the coupler (70) to receive the connector part (14) and the planes (16) of the waveguide (12) within the proximal part (61).

The sheath coupler (70) is generally hollow and includes a threaded cavity (72) that extends inwardly away from the wall of the proximal end (74) of the coupler (70). Once the waveguide (12) has been operatively coupled to the transducer (82) in the manner described above, the sheath assembly is slid over the waveguide (12). In particular, the blade (24) is inserted through the threaded cavity (72) followed by the waveguide (12). Thereafter, the sheath coupler (70) is threadedly attached to the transducer housing (84) by threaded engagement of the threaded boss (89) within the threaded cavity (72), with the proximal end wall (74) of the coupler (70) abutting the end wall (87) of the transducer housing (84). Once assembled in this manner, at least a portion of the blade (24) extends beyond the wall of the distal end (62) of the sheath (60), as seen in FIG. 1. In other words, in some embodiments, a proximal portion of the blade (including the proximal portions of the blade faces, described later herein) is positioned within the sheath, while a distal portion of the blade extends beyond the wall of the distal end of the sheath (as depicted in FIG. 1). Of course, it will be understood that the waveguide (12), blade (24), and / or sheath assembly may be configured such that more or less of the blade (24) extends beyond the distal end ( 62) of the sheath (60) shown in FIG. 1 (see, for example, FIGS. 3A and 3B). In general, a sufficient amount of the blade (24) should protrude beyond the distal end of the sheath (60) to provide adequate visualization, reach, and manipulation of the blade for cutting, dissection, and coagulation during use. Without having too much of the blade (24) exposed so that there is a greater risk of inadvertent contact between the blade (24) and the tissue.

In the embodiment shown in FIG. 1, between about 0.5 and about 2.5 cm of the blade (24) extends beyond the wall of the distal end (62) of the sheath (60). In other embodiments, between about 1.0 and about 2.0 cm of the blade (24) extends beyond the wall of the distal end (62) of the sheath (60). In still other embodiments, between about 15% and about 85% of the distal 1/4 wave, or between about 30% and about 70% of the distal 1/4 wave of the blade (24) is exposed. The distal 1/4 wave is the region that extends between the most distal vibratory node and the distal tip (26) of the blade, that is, approximately the length of the blade (24) extending from approximately the most distal node distal to the distal tip (26).

During use of the ultrasound surgical devices and blades described herein, various forces applied to the blade (24) will tend to cause lateral deflection of the waveguide (12) within the sheath (60). To avoid contact between the inner wall of the sheath (60) and the blade (24) and the waveguide (12), thus limiting or preventing possible damage to the ultrasound device (10), as well as damping of the standing wave, one or more spacers are provided between the waveguide (12) and the interior of the sheath (60) to maintain the waveguide (12) in the center of the sheath (60) (i.e., the longitudinal axis of the waveguide (12) aligned with the longitudinal axis of the sheath (60)). In the embodiment shown in FIG. 1, the elastic rings (17A, 17B) are provided on the outside of the waveguide (12), and comprise, for example, silicone rings. Since the amplitude of the longitudinal vibration of the waveguide (12) at the drive frequency (for example, 55 kHz) during its use is zero at the nodes of the standing wave, the elastic rings (17A, 17B) are placed at or near the vibratory nodes of the waveguide (12) to limit the damping of the standing wave. The rings (17A, 17B) also dampen any vibrations that have frequencies other than the drive frequency, as the nodes of vibrations of other frequencies will generally not match the node locations for the drive frequency.

The snap rings (17A, 17B) can be supported and held in place in a variety of ways known to those of skill in the art. For example, in the embodiments shown in FIGS. 6, 7 and 14, an annular bracket (220, 320, 420) is provided for a snap ring on the waveguide, and the snap ring can, for example, be inserted molded onto the bracket (220, 320, 420) or affixed to the annular support in other ways known to those skilled in the art (eg, with adhesives, gluing, etc.). Annular supports can be formed, by For example, by turning. As another alternative, and as seen in the embodiment of FIGS. 18 and 19, a circumferential groove (621) is provided in the waveguide (eg, by turning so that two adjacent rings are formed with the groove positioned between them). The snap ring can then be mechanically held in position by trapping the ring within the groove (621). Similar arrangements can be used to attach additional snap rings around the waveguide. In some embodiments, the snap rings (17A, 17B) are provided at or near two or more vibratory nodes, depending in part on the length of the waveguide.

As is known to those skilled in the art, the waveguide can provide a variety of other features (12). For example, the waveguide (12) shown in FIG. 1 includes several segments of varying diameter, with tapers (18A, 18B, 18C) that provide a smooth transition between segments of different diameters. In the example embodiment shown in FIG. 1, the first segment (12A) is located in the adjacent planes (16) and has a diameter smaller than that of the region of the planes (16) to amplify the standing vibratory wave. A first taper (18A) is located at the distal end of the first segment (12A), and provides a smooth transition from the largest diameter of the first segment (12A) to the smallest diameter of the second segment (12B). Similarly, a second taper (18B) is located at the distal end of the second segment (12B), and provides a smooth transition from the smaller diameter of the second segment (12B) to the larger diameter of the third segment (12C). . Finally, a third taper (18C) is located at the distal end of the third segment (12C) (adjacent elastic ring (17B), at the most distal vibratory node of the waveguide), and provides a smooth transition from the diameter largest of the third segment (12C) of the waveguide (12) to the smallest diameter of the blade (24). These changes in diameter serve, among other things, to adjust the amplitude and / or frequency of the vibratory wave propagating the length of the waveguide. It will be understood, however, that this is only an exemplary waveguide arrangement. Alternative embodiments include any number of segments of varying diameters, depending, in part, on the desired length of the waveguide (which will depend, for example, on the intended use of the instrument).

The ultrasound surgical device comprising the waveguide (12) and the blade (24) can be manufactured from any of a variety of materials, in particular various medically and surgically acceptable metals such as titanium, titanium alloy (for example, Ti6A14V), aluminum, aluminum alloy, or stainless steel. The waveguide (12) and blade (24) shown in FIG. 1 are formed as a single unit, manufactured from a single metal rod that has been milled to provide the characteristics depicted. Alternatively, the waveguide and blade may comprise two or more separable components thereof of different compositions, with the components coupled together, for example, by means of adhesive, welding, a threaded bolt, and / or other suitable ways. known to those of skill in the art. For example, the waveguide (12) can be configured as two pieces joined in or between planes (16) and the first segment (12A). Similarly, blade (24) can be constructed separately from waveguide (12) and attached to the distal end of waveguide (12).

It will also be understood that the ultrasound surgical device comprising the waveguide (12) and the blade (24) can be used without the sheath assembly simply by operatively engaging the proximal end of the waveguide (12) (ie that is, the connector portion (14)) to the transducer (82) (by means of the threaded mounting bolt (89)). However, the sheath (60) not only protects the waveguide (12), but also prevents inadvertent contact between the waveguide (12) and the patient, medical personnel, or the surgical environment. Such contact will not only dampen the vibration of the waveguide (12), but can also cause injury to the patient or medical personnel, since the waveguide (12) vibrates by ultrasound.

Figures 3A and 3B represent an alternative embodiment of an ultrasound surgical device (110), where the device (110) is configured as an ultrasound shear (also known as a jaw coagulator or ultrasound forceps) that It has a jaw member (150) supported pivotably on an adjacent curved blade (124). The jaw member (150) is adapted for selective engagement with a face or an edge of the blade (124) so as to facilitate the simultaneous cutting and coagulation of tissue driven against a face or an edge of the blade (124) by the clamp element (150). Blade (124) is similar to blade (24) in FIG. 1 or can be configured similarly to the various other curved blade embodiments described herein. In the embodiment shown, the jaw member (150) is positioned and configured for selective engagement with a concavely curved upper face of the blade (124).

Apart from the blade (124) and the jaw member (150), the ultrasound surgical device (110) is similar to the apparatus shown and described in US Patent No. 5,322,055. As in the previous embodiment, the curved blade (124) is provided at the distal end of an elongated waveguide (112). While the waveguide 112 and blade 124 are represented as being of unitary construction, in alternative embodiments the waveguide 112 comprises two or more parts joined together (for example, by screw connection). Similarly, although the blade (124) is represented as being an integral part of the waveguide (112), in alternative embodiments the blade (124) has a separate structure and is attached to the distal end of the waveguide. waves (112), such as, by means of a threaded joint. The ultrasound surgical device (110) also includes a hollow cylindrical sheath (160) in which is placed at least a part of the waveguide (112) and optionally a part of the blade (124).

As in the previous embodiment, although at least a part of the waveguide (112) is located within of the sheath (160), the sheath (160) is not attached directly to the waveguide (12). Instead, and as detailed below, the waveguide 112 is operatively attached at its proximal end to a transducer 182, and the proximal end of the sheath 160 is secured within the handle ( 172).

The ultrasound surgical device (110) further includes an ultrasound transducer (182) mounted on the handle (172), as shown. The transducer (182) can be removably mounted on the handle (172), such as by threaded engagement therewith, or it can be secured in or on the handle (172). The transducer (182) includes a housing (184) that is configured to facilitate grasping and manipulation of the surgical device (110) in conjunction with the stationary handle (174) of the handle (172). The proximal end of the transducer housing (184) includes an electrical connector (eg, a plug or socket) for operative connection to a generator. Therefore, an electrical drive signal comprising an ultrasonic frequency alternating current will be supplied from the generator to the transducer (182) via a cable operatively connected to the electrical connector in the transducer housing. As in the previous embodiment, the transducer (182) converts the drive signal into a stationary ultrasonic vibratory wave at the transducer, which includes the horn of the transducer (or speed transformer) (185).

Although not shown in FIGS. 3A or 3B, a threaded mounting bolt is attached to the distal end (186) of the transducer tube (185), as threaded and adhesively attached within a threaded hole in the distal end (186) of the transducer tube. (185). Therefore, as in the previous embodiment, this threaded bolt extends distally away from the distal end (186) of the transducer tube (185), and this distal end (186) of the transducer tube (185) is locates at an antinode of the standing vibratory wave produced by the transducer (182) (for example, at 55 kHz). Similar to the previous embodiment, the proximal end of the waveguide 112 includes a threaded hole (not shown) that extends inwardly (i.e. distally) from the proximal end of the waveguide. (112). This threaded hole is sized and configured to threadably receive the mounting bolt at the distal end of the transducer horn (185), such that the waveguide (112) is operatively coupled to the transducer (182). threading the waveguide onto the transducer horn mounting bolt (185). When coupled in this manner (ie, as seen in FIG. 3B), the standing vibratory wave produced in transducer (182) propagates along the length of waveguide (112).

The sheath (160) can be attached to the handle (172) in a variety of ways known to those skilled in the art, such as by welding, adhesive, mechanical fasteners, and / or stamping. In the example embodiment shown in FIGS. 3A and 3B, the proximal end of the sheath (160) and the waveguide (112) are secured within the handle (172) by a mounting pin (191).

As seen in FIG. 3A, at least a portion of the blade (124) extends beyond the wall of the distal end (162) of the sheath (160). Once again it will be understood that the waveguide 112, blade 124, sheath 160, and / or handle 172 can be configured such that more or less of the blade extends beyond of the distal end of the sheath (160) shown in FIG. 3A. In this case, all of the faces of the blade (ie, the curved portion of the blade) extend beyond the wall of the distal end (162) of the sheath (160). As in the embodiment described above, one or more snap rings (117) are provided on the outside of the waveguide (112) (e.g. silicone rings) and act as spacers that not only hold the guide of waves (112) centered with the sheath (160), but are also located at the vibratory nodes of the waveguide (112) to limit the damping of the standing wave at the drive frequency, while also damping the frequencies different from the drive frequency.

Jaw member (150) includes a pad (151) mounted thereon to compress tissue against a face or edge of blade (124) to facilitate cutting and coagulation of tissue. The pad (151) is formed of a polymer or other compatible material, and engages an edge or face of the blade (124) when the jaw member (150) is rotated to its fully closed position shown in FIG. 17. The pad (151) may comprise, for example, PTFE or polyimide (PI), with or without added fillers such as glass, metal, and / or carbon. In some embodiments, pad 151 comprises a high temperature resistant material. The pad (151) is attached to the jaw member (150) by, for example, an adhesive or a mechanical fastener. As seen in Figures 3A and 3B, the exposed surface of pad 151 provides a curved tissue engaging surface. In the embodiment shown, this tissue engaging surface has a curvature that corresponds to the curvature of the corresponding part of the first face of the blade.

Furthermore, as best seen in FIG. 16, teeth (152) are formed on the holding surface of the pad (151) to improve grip and manipulation of the tissues, even when the blade (124) does not vibrate, thus allowing the surgical device to (110) is used like conventional forceps when not used to cut / coagulate tissue. The teeth (152) are provided in two rows, with a recessed region (152) between them. The recessed region (152) is shaped and configured for mating engagement with an adjacent face of the blade (124), as best seen in FIG. 16. By conforming the surface of the recessed region (152) with that of the adjacent face of the blade (124), there are no gaps between the tissue pad (151) and the blade when the tissue pad is held against the face adjacent to the blade, thereby ensuring that the tissue is cut completely along the blade. It will also be appreciated that the distal end of the sheath (160) is tapered to limit the entry of tissue into the interior of the sheath (160) during use.

The proximal end of the jaw member (150) is pivotally mounted in the sheath (160), adjacent to the distal end thereof, by means of a pivot pin (153). Jaw member (150) is also pivotally attached to the distal end of an actuator rod (179) on pivot pin (154). Actuator rod (179) mounts to handle (172) for linear movement parallel to the longitudinal axis of waveguide (112), and extends outward from handle (172) directly above sheath ( 160). From the open position of FIG. 3A, the linear movement of the actuator rod (179) in a distal direction (that is, toward the blade (124)), causes the jaw arm to pivot toward its closed position, such that the pad (151) will eventually engage. with one face of the blade (124) (see FIG. 17). Similarly, from the closed position, linear movement of the actuator rod (179) in a proximal direction (ie, toward the transducer (182)), causes the jaw arm to pivot toward its open position of FIG. 3A.

To perform a linear and longitudinal movement of the actuator rod (179), a handle (175) is pivotably mounted on the handle (172), as shown. The handle (175) is pivotally attached within the handle (172) on the pivot pin (176), and the distal end of the handle (175) is pivotally attached to the proximal end of the actuator rod ( 179) on the pivot pin (177) inside the handle (172). Therefore, the pivoting movement of the handle (175) away from the handle (172) causes the jaw element (150) to rotate towards its open position (FIG. 3A), while the pivoting movement of the handle (175) towards the handle (172) causes the jaw element (150) to rotate towards its closed position, the tissue clamping position.

As mentioned above, the blades depicted and described herein have at least one curved surface along with a number of blade edges suitable for ultrasonic cutting of tissue. These blades can be manufactured from turned billet (eg round billet) using only finishing burs and no milling on the Z-axis, while still providing multiple blade edges suitable for cutting tissue.

The curved blades depicted and described herein are provided at the distal end of a waveguide, and have a curved portion that includes at least five faces that extend longitudinally along at least a portion of the length of the waveguide. knife. Each of the faces of the blade is flat across its width, which width extends perpendicular to the protruding longitudinal axis (L) of the waveguide. Along their respective lengths (i.e. the direction orthogonal to their respective widths), each of the blade faces is either flat or includes one or more curved segments (with or without one or more flat segments) , with each of the curved segments of an individual face being curved in the same direction (however, that curvature can be positive and / or negative). At least one of the faces of the blade includes at least one of said curved segments. In some embodiments where the curved portion of the blade has an even number of faces (eg, six), two opposite faces (ie, faces on opposite sides of the blade) have at least one curved segment. The direction of curvature of the curved segments of an individual face does not change along its length, the gradient of curvature on the surface of the curved segments of each face being non-zero in one direction and zero in the perpendicular direction ( that is, across their widths). Therefore, the axes of curvature of each of the curved segments of an individual face are parallel to each other (as seen, for example, in FIG. 5). Furthermore, the axes of curvature of each of the curved segments of the blade faces are perpendicular to a plane that includes the longitudinal axis (L) of the waveguide (that is, the blade faces do not include any segment curved having an axis of curvature that is not perpendicular to a plane that includes the longitudinal axis of the waveguide). Therefore, the included angle between the adjacent faces is also constant along the length of the curved part of the blade.

Consequently, each of the faces of the curved portion of the blade comprises a developable surface, thus facilitating the manufacture of the blade from turned billet (for example, round billet) using a finishing mill and movement only in the X and Y axes of the workpiece (that is, the blade material, eg round billet) and the cutter relative to each other. During milling, no movement or cutting in the Z axis is required, as each of the blade faces is flat and / or includes one or more straight cylindrical surfaces (circular or elliptical cylindrical surfaces) or other curved surface on a only direction. It will be understood that the blades described herein can be manufactured from any turned billet, including not only the straight or conical cylindrical billet but also the straight or conical elliptical turned billet. (The configuration of the blade faces described above can be better understood with reference to the method of producing the blade faces from the round billet, as further described herein).

The intersection of each pair of adjacent faces of the curved portion of the blade defines a cutting edge, which extends along at least a portion of the length of the blade. Since each adjacent face of the blade does not necessarily curve in the same way, a variety of shapes and configurations of the cutting edge can be provided on the same blade to give the clinician more cutting options.

In some embodiments, the five or more faces of the blade, and therefore the five or more cutting edges between them, extend to the distal tip (26) of the blade (eg, FIGS. 6A-6E). In other embodiments (eg, FIG. 15), one or more of the blade faces ends in a cylindrical face (527) (or other turned surface). The cylindrical face (527) results when two adjacent faces intersect along the length of the blade, but adjacent to their distal ends that intersection extends out of the turned profile of the billet used to make the blade. In the embodiments shown in FIG. 15, the cylindrical face (527) comprises a part of the cylindrical billet from which the blade (524) has been manufactured. I know It will be understood, however, that the blade described herein can be made from any turned billet, including not only the cylindrical billet but also, for example, the elliptical turned billet.

In some embodiments, the curved portion of the blade has six faces arranged as three pairs of opposite faces, such that the cross-sectional shape of the blade in any plane perpendicular to the longitudinal axis of the waveguide through of the curved part of the blade (except through some transition segments, as described below) is a hexagon. The included angle between the adjacent faces in these embodiments is constant along the length of the curved portion of the blade, and each is between about 100 and about 140 degrees. In a particular embodiment, all included angles between adjacent faces of a blade having a curved portion with six faces are approximately 120 degrees (eg, blade 424 in FIG. 14).

The proximal end of the blade in some embodiments includes a cylindrical section between the distal end of the waveguide and the various faces of the blade. The blade (24), for example, includes a cylindrical portion (25) located between the taper (18C) adjacent the most distal node of the waveguide (12) and the proximal ends of the blade faces (28, 30 , 32, 34, 36, 38) (see FIGS. 1 and 4A). In other embodiments, particularly when a taper is not provided at the most distal node, the blade includes a cylindrical portion located between the most distal node of the waveguide and the various faces (that is, when there is no taper between the most distal node and the blade). Furthermore, in still other embodiments, said cylindrical portion is not included at the proximal end of the blade.

FIGS. 4A-4E depict various views of the blade (24) which, in this embodiment, includes a curved portion with six faces (28-38) extending distally away from the cylindrical portion (25) to the distal tip (26 ). In this particular embodiment, each face (28-38) includes a curved transition segment (A), a plan median segment (B), and a curved distal segment (C). The transition segments (A) on each face provide a smooth transition from the cylindrical portion (25) to the middle and distal segments (B, C) of the curved portion of the blade, and gradually increase in width in the distal direction (ie that is, towards the distal tip (26)). Transition segments (A) are not only required by using a finishing mill to form the faces of the cutter on the turned billet, but transition segments (A) help reduce stress at the intersection of the faces and the cylindrical part (25). However, transition segments (A), as well as the edge between a transition segment (A) and the adjacent face (eg, an adjacent transition segment) are also usable parts of the blade. Therefore, each of these transition segment edges can be used to cut and / or cauterize tissue.

The transition segment (A) of each of the blade faces is flat across its width and curves in a single direction along its length. In the embodiment shown in FIGS. 4 and 5, the middle segment (B) of each of the blade faces, on the other hand, is flat across its width and also flat along its length, extending at an angle to the longitudinal axis of the waveguide such that the blade (24) tapers along the midsegments (B). In alternative embodiments, one or more of the midsegments (B) extend parallel to the longitudinal axis (L) of the waveguide. Finally, each distal segment (C) of each of the blade faces (24) is flat across its width and curves (in a single direction) along its length. In alternative embodiments, one or more (but not all) of the distal segments (C) are flat along their respective lengths.

As mentioned above, the curved portion of the blade (24) has six faces (28-38) that extend distally away from the cylindrical portion (25) to the distal tip (26). The faces of the blade (24) are arranged as three pairs of opposite faces, such that the shape of the cross section of the blade in any plane perpendicular to the longitudinal axis (L) of the waveguide through any point of the midsegments (B) or the distal segments (C) is a hexagon. The included angle between the adjacent faces is constant along the length of the blade, and each is between about 100 and about 140 degrees. In the embodiment shown in FIGS. 4A-4E, all included angles between adjacent faces are approximately 120 degrees, such that the cross-sectional shape of the blade in any plane perpendicular to the longitudinal axis (L) of the waveguide through any point middle segment (B) or distal segment (C) is an equiangular hexagon.

It should be noted that an equiangular hexagon simply means that the included, that is, interior angles are identical, and the opposite sides of the hexagon are parallel to each other. However, since the cross-sectional shape of the equiangular hexagon described above is defined in a plane perpendicular to the longitudinal axis (L) of the waveguide and the opposite faces, although parallel through their widths and only curving in a single direction, they may have different amounts of curvature, the opposite sides of this equiangular hexagon not necessarily having the same length. Therefore, the blades described herein, although they can be manufactured using only conventional end mills and without Z-axis milling, can have multiple curved cutting edges that do not necessarily curve in a single direction (despite the fact each individual face curving in only one direction).

Of course, it will be understood that the included angle between adjacent faces in alternate embodiments will depend, in part, on how many faces are provided on the blade. For example, in some embodiments of a blade that has five faces, each of the included angles between the adjacent faces is between about 88 and about 128 degrees, or, in some cases, each is about 108 degrees, such that the cross-sectional shape of the blade in any plane perpendicular to the longitudinal axis of the waveguide through part blade curve (except through some transition segments, where any) is an equiangular pentagon. Similarly, in some embodiments of a blade that has seven faces, each of the included angles is between about 108 and about 148 degrees, or, in some cases, each is about 128 degrees, such that the The shape of the cross section of the blade in any plane perpendicular to the longitudinal axis of the waveguide through the curved portion of the blade (except through some transition segments, where any) is an equiangular heptagon. Similarly, in some embodiments of a blade that has eight faces, each of the included angles is between about 115 and about 155 degrees, or, in some cases, each is about 135 degrees, such that the shape of the cross section of the blade in any plane perpendicular to the longitudinal axis of the waveguide through the curved part of the blade (except through some transition segments, where any) is an equiangular octagon.

In still other embodiments, the blade can be configured to have a greater variation in included angles than specified in the preceding paragraphs. Therefore, at least one of the included angles between adjacent faces is more than 20 degrees, more than 30 degrees, or more than 45 degrees lower than at least one of the other included angles along at least a portion of the knife. For example, the blade (624) shown in FIGS. 18 and 19 have five faces such that the cross-sectional shape of the blade in any plane perpendicular to the longitudinal axis of the waveguide through the curved distal segments (C) of the blade (624) is a pentagon . However, although four of the included angles between adjacent faces are approximately 120 degrees, the fifth included angle (a) is approximately 60 degrees. Therefore, the cutting edge (637) is sharper than the other four cutting edges.

As also seen in Figures 4A-4E and 5, since the transition segments (A) of faces (28-38) do not all have the same length, the cross-sectional shape of the blade in a plane perpendicular to the Longitudinal axis (L) of the waveguide through some parts of the transition segments (A) will include parts of a cylindrical surface (40) corresponding to that of the round billet from which the blade is manufactured (see, for example, FIG.

12F, where 28A designates the transition segment of the first face (28) of the curved part of the blade (24)). In some embodiments, the transition segments A comprise less than half the length of the curved portion of the blade, or even less than one third of the length of the curved portion of the blade.

In the alternate embodiment depicted in Figures 18 and 19, while the curved distal segments (C) comprise five faces, the transition segments (A) include a sixth face (638A) to facilitate provision of an included angle ( a) reduced between two of the faces of the distal segment. However, each face (628, 630, 632, 634, 636) includes a curved transition segment (A), a flat mid segment (B), and a curved distal segment (C). As before, the transition segments (A) on each face provide a smooth transition from the cylindrical portion (625) to the middle and distal segments (B, C) of the blade. Each transition segment (A) of each of the blade faces, as well as the transition face (638A), is flat across its width and curves in a single direction along its length. The middle segment (B) of each of the blade faces, on the other hand, is flat across its width and also flat along its length, extending parallel to the longitudinal axis of the waveguide. Lastly, the distal segment (C) of each of the blade faces is flat across its width and curves (in a single direction) along its length. Furthermore, since the blade (524) in FIG. 15, the first face (628) and, in part, the second and fifth faces (630, 636), terminate in a cylindrical face (627).

As best seen in FIGS. 4A, 4B and 5, the first face (28) intersects the second face (30) along the cutting edge (29), through the transition segment (A), the middle segment (B) and the distal segment ( C) of the blade (24). Similarly, the second face (30) intersects the third face (32) along the cutting edge (31), the third face (32) intersects the fourth face (34) along the cutting edge (33), the fourth face (34) intersects the fifth face (36) along the cutting edge (35), the fifth face (36) intersects the sixth face (38) along the cutting edge (37), and the sixth face (38) intersects the first face (28) along the cutting edge (39). If desired, the cutting edges can be polished to smooth the edges or they can be ground to sharpen the edges. You can also polish the entire blade to improve surface finish, improve blade life (avoid fatigue), and / or adjust cutting speed. Regarding the three pairs of opposite faces of the blade (24), the first face (28) is in opposite relation to the fourth face (34), the second face (30) is in opposite relation to the fifth face (36), and the third face (32) is in opposite relation to the sixth face (38). Since each included angle between the adjacent faces is constant along the length of the curved part of the blade (24), and is approximately 120 degrees, the curvature axes of the curved segments of each pair of opposite faces are parallel each other, that is, each pair of opposite faces only curves in the same direction (although that direction of curvature can be positive or negative). This is best seen, for example, in FIG. 5, which represents a side plan view of the blade (24) (and is the same view as FIG. 4B).

As shown in FIG. 5, the transition segments (28A, 34A) of the opposite first and fourth faces (28, 34) curve along their lengths, the middle segments (28B, 34B) are flat (along their lengths and widths), and the distal segments (28C, 34C) curve along their lengths. Each of these segments (28A-C, 34A-C) is flat across its width, where the width extends perpendicular to the longitudinal axis (L) of the waveguide (12) (i.e., perpendicular to the plane of FIG. 5). The curved segments (28A, 28C, 34A, 34C) are all curved in the same direction, in such a way that their axes of curvature (D ', E', F ', G') are parallel to each other and are perpendicular to a plane that includes the longitudinal axis (L) of the waveguide (ie, perpendicular to the plane of FIG. 5). Of course, while the curved segments (28A, 28C, 34A, 34C) all curve in the same direction, the distal segment (34C) of the fourth face (34) is curved negatively (negative radius of curvature (F )) although the other curved segments (28A, 28C, 34A) are positively curved (positive radii of curvature (D, E, F)). As used herein, a concave surface has a positive radius of curvature, while a convex surface such as the distal segment (34C) of the fourth face (34) has a negative radius of curvature.

In some embodiments of the blades described herein, the transition segments on each face are concave (eg, 28A and 34A in FIG. 5). Therefore, the transition segments effectively provide a taper that reduces the cross-sectional size of the blade. In addition, in some embodiments of the blades described herein (e.g., the blades (24, 124, 224)), when one of the middle or distal segments of each pair of opposing faces is concave (e.g. 28C in FIG.

5), the corresponding middle or distal segment of the opposite face is convex (eg, 34C in FIG. 5). Furthermore, in these embodiments the radius of curvature of the concave middle or distal segment of one blade face is equal to or greater than the corresponding middle or distal segment of the opposite face. For example, in the embodiment shown in FIG. 5, the radius of curvature (E) of the concave distal segment (28C) of the first face (28) is greater than the radius of curvature (G) of the convex distal segment (34C) of the fourth face (34). In this way, the cross-sectional area of the curved portion of the blade in these embodiments will not increase along any part of its length. Rather, the cross-sectional area of the curved portion of the blade will decrease between its proximal and distal ends such that the blade tapers along its length and the blade has its narrowest portion at the distal tip ( 26).

Although each of the six faces (28-38) of the blade (24) includes a single midsegment (28B-38B), any number of midsegments of varying curvature (or no curvature) can be provided between the transitional segments. (28A-38A) and distal segments (28C-38C). In the embodiment shown in FIG. 5, although the midsegments of all faces 28-38 are not curved (ie, they have a zero curvature gradient), they are taper such that the distance between the opposing midsegments decreases in the distal direction.

It will be understood that any number of flat and curved segments can be provided on any of the various faces of the curved portion of the blade. For example, in some embodiments, each face has at least one segment that is curved, just as each face has a curved distal segment, with or without transition and distinct middle segments, each of which (transition and middle segments ) can be straight or curved along its length. In other embodiments, all of one or more faces is curved, with a single radius of curvature for the entire length of the face (eg, the first face (228) of the blade (224) in FIGS. 6A-6E).

Figures 6A-6E depict an alternate embodiment of a blade (224) having six faces (228-238) extending distally away from the cylindrical portion (225) toward the distal tip (226). In this particular embodiment, each face (228-238) includes a transition segment (A) and a distal segment (C) (there is no flat mid-segment on any of the six faces). The transition segments (A) on each face provide the transition from the cylindrical portion (225) to the distal segments (C) of the blade. Like the previous embodiment, since the transition segments (228A-238A) provide a taper that reduces the cross-sectional area of the blade from the cylindrical part (225) towards the rest of the curved part of the blade. blade, the transition segments (228A-238A) gradually increase in width in the distal direction (ie, toward the distal tip (226)). Unlike the blade (24), the distal end of the transition segments (228A-238A) are located at varying distances from the distal end of the waveguide (212). Once again, the transition segment (A) of each of the blade faces is flat across its width and curves in a single direction along its length, each transition segment being (228A-238A ) concave. Similarly, the distal segment (C) of each of the blade faces is flat across its width and curves (in a single direction) along its length. However, in this embodiment, each distal segment of the blade faces comprises a complex curve of radius that changes continuously, however, that curvature is nevertheless in a single direction along the length of the segment. distal (eg, as depicted schematically in FIG. 20).

As before, the six faces (228-238) of the blade (224) are arranged as three pairs of opposite faces, such that the cross-sectional shape of the blade in any plane perpendicular to the longitudinal axis (L ) of the waveguide through any point on the distal segment (C) is a hexagon. The included angle between adjacent faces is constant along the length of the blade, and each is approximately 120 degrees, such that the cross-sectional shape of the blade in any plane perpendicular to the longitudinal axis (L) of the waveguide through any point on the distal segment (C) is an equiangular hexagon.

The first face (228) intersects the second face (230) along the cutting edge (229), the second face (230) intersects the third face (232) along the cutting edge (231), the third face ( 232) intersects the fourth face (234) along the cutting edge (233), the fourth face (234) intersects the fifth face (236) along the cutting edge (235), the fifth face (236) intersects the sixth face (238) along cutting edge (237), and sixth face (238) intersects first face (228) along cutting edge (239). Regarding the three pairs of opposite faces of the blade (224), the first face (228) is in opposite relation to the fourth face (234), the second face (230) is in opposite relation to the fifth face (236), and the third face (232) is in opposite relation to the sixth face (238). Since each included angle between adjacent faces is constant over the length of the blade (224), and approximately 120 degrees, the curvature axes of the curved parts of each pair of opposite faces are parallel to each other, that is, each pair of Opposite faces only curve in the same direction (although that direction of curvature can be positive or negative, as in the previous embodiment). As in the case of blade (24), when a distal segment (C) of one face (228-238) is concave, the distal segment (C) of the opposite face is convex (for example, the distal segment of the first face (228) is concave, and the distal segment of the opposite fourth face (234) is convex).

FIG. 7 depicts another alternate embodiment of a blade (324) having six faces (328-338) that intersect each other at included angles of approximately 120 degrees. Again each face includes a transition segment (A), a mid segment (B), and a distal segment (C). As before, the transition segments (328A, 330A, 332A, 334A, 336A, 338A) are flat across their respective widths and curve (concavely) in a single direction along their respective lengths. However, in this embodiment, the middle and distal segments (B, C) of the opposing second and fifth faces (330, 336) are flat throughout their entire lengths. The faces (328, 332, 334, 338) are flat along their respective lengths at the midsegments (B), but curve in a single direction along their respective lengths at the distal segments (C). Also in this embodiment, each pair of opposing faces that curve along their distal segments (C) have the same radius of curvature, such that the cross-sectional shape of the blade (324) in any The plane perpendicular to the longitudinal axis (L) of the waveguide through any point of the midsegment (B) or the distal segment (C) is an equiangular, semi-regular hexagon (the opposite sides of the hexagon are congruent, that is, of equal length). Therefore, the cross-sectional size of the blade (324) has no taper apart from the transition segment (A). Furthermore, the axis of the midsegment (B) is parallel to the longitudinal axis of the waveguide.

FIGS. 8A-8D, 9A-9E, 10A-10E, 11A-11E and 12A-12F represent a method of manufacturing the blade (24) from a segment (42) of round billet, where the taper (18C) in the distal end of the waveguide (12) has been omitted from the FiG. 8A-8D, 9A-9E, 10A-10E, 11A-11E, and 12A-12F for clarity purposes. Waveguide (12) and blade (24) are machined from a single round billet, and features omitted from waveguide (12) (e.g., tapers (18)) can be formed by methods known to those of skill in the art. In particular, the diameter of the segment 42 of the round billet (shown in FIGS. 8A-8D) has been reduced in FIGS.

9A-9E to provide not only the desired diameter of the third segment (12C) of the waveguide (12), but also an annular support (20) for the elastic ring (17B) that can, for example, be inserted molded over the support (20) or applied to the support (20) in other ways known to those skilled in the art. The support (20) and the distal cylinder (42A) can be formed, for example, by rotating the round billet on a lathe to reduce its diameter, leaving the distal cylinder (42A) at the end of the round billet with the same diameter as ( or less than) the diameter of the original segment (42) of the round billet. The distal cylinder (42A) corresponds to the middle and distal segments (B, C) of the final blade (24). Alternatively, the blade faces can be milled into the full diameter round billet.

After reducing the size of the round billet to the configuration shown in FIGS. 9A-9E, the six faces of the blade (24) are machined using one or more end mills to produce the configuration shown in FIGS. 10A-10E. However, no Z-axis milling is required, and all six faces can be milled using only three orientations of the round billet. For example, the first and fourth faces (28, 34) are milled into the round billet using a finishing mill (44) as shown in FIGS. 10A-10E and 13A-13B. The workpiece (the round billet, optionally reduced in size as shown in FIGS. 9A-9E) is placed on the X-Y table of a milling machine, as shown in FIGS. 13A and 13B. The workpiece is then advanced in the X and Y directions, without rotation of the workpiece, at the same time as the finishing mill is rotated (about an axis facing Z). As a result, the first face (28) is milled into the workpiece, where the first face (28) is flat across its width (ie, the Z direction in FIG. 13B). The fourth face (34) is milled in the same way, without the need to rotate the part around its longitudinal axis (L), but simply by moving the part in the Y direction to reorient it before milling the fourth face (34). (Alternatively the workpiece can be rotated 180 degrees about its longitudinal axis from the position shown in FIG. 13 to machine (mill) the fourth face (34)).

The workpiece is then rotated (clockwise, viewed from the distal end) about its longitudinal axis (L) 60 degrees, and the third and sixth faces (32, 38) are milled using one or more end mills in the same manner (ie only with X and Y movement of the workpiece relative to the end mill that is rotating about the Z axis) (see FIGS. 11A-11E). Finally, the workpiece is rotated about its longitudinal axis (L) another 60 degrees, and the second and fifth faces (30, 36) are milled using one or more end mills in the same way as before (i.e. , only with X and Y movement of the workpiece relative to the rotary finishing mill) (see FIGS. 12A-12F). It will of course be understood that the cutting order of the pairs of opposite faces can be changed. Similarly, opposing faces can be milled by moving the rotary end mill in the X and Y directions relative to a stationary workpiece, or even a combination of these techniques by performing an X and Y movement of the workpiece. relative to a rotary finishing mill (ie, by an X and Y direction movement of both the workpiece and the rotary finishing mill).

FIG. 14 depicts yet another alternate embodiment of a blade (424) having six faces that meet they intersect with an included angle of approximately 120 degrees. As in previous embodiments, each face is flat across its width and curves in a single direction along its length. In this embodiment, however, the first face (428), the second face (430), and the sixth face located adjacent to the first face (428) (not visible in FIG. 14) are continuously curved to along their entire lengths, having a positive elliptical curvature (that is, concavely curved). As also used herein, a concave surface has a positive curvature, while a convex surface has a negative radius of curvature. As also used herein, the axis of curvature of a curved, elliptically shaped surface such as the first face (428) whose curvature is defined by an ellipse (D) in FIG. 14, is defined as a line extending through the center point of the ellipse parallel to the width of the blade face and perpendicular to the longitudinal axis (L). The axis of rotation for other complex curves can be defined in a similar way.

As shown in FIG. 14, along its length, the curvature of the first face (428) follows a part of an ellipse (D) that is inclined with respect to the longitudinal axis (L) of the waveguide. Therefore, as seen in FIG. 14, the major axis (E) of the ellipse (D) is not parallel to the longitudinal axis (L), but is inclined with an included angle of approximately 5 degrees. Of course, the elliptical path of the first face (48) does not have to be inclined with respect to the longitudinal axis (L) or it can be inclined by various degrees (for example, up to about 20 degrees, or between about 2 and about 10 degrees. degrees). Since the first face (428) curves continuously along the elliptical path for its entire length, the first face (428) does not include a separate and distinct transition segment. Instead, the concave transition segment is incorporated into the first face (428), which curves continuously. The second face (430) and the sixth face of the blade (424) have a curvature of similar elliptical shape, although not necessarily following elliptical curves identical to the ellipse (D) (for example, they can be inclined or not inclined, have different eccentricities and / or different radii). Therefore, the second and sixth faces of the blade 424 also do not have separate and distinct transition segments.

The distal segments (C) of the opposite faces (i.e., the third face (432) in opposite relation to the sixth face, the fourth face (434) in opposite relation to the first face (428), and the fifth face in opposite relation to the second face (430)) are also elliptically curved in a similar manner, and thus comprise convexly curved elliptical surfaces. These opposite faces also have transition segments (A) (eg, transition segment (432A) of third face (432)) that curve elliptically and concave, as described hereinbefore. In this particular embodiment, the convexly curved opposing distal segments follow sloping ellipse portions similar to their opposing concave faces. Thus, each pair of opposite faces is curved along their lengths in the same singular direction, with one face of each pair curved concavely along its entire length, and the other face having the opposite of each pair a convexly curved distal segment and a concavely curved transition segment.

In addition, the blade (424) is also symmetrical with respect to a plane that includes the longitudinal axis (L) of the waveguide (that is, a plane parallel to the plane of FIG. 14 that includes the longitudinal axis (L) Because of this, as well as the curvature of the blade, the blade will vibrate both longitudinally and transversely (ie, in the X and Y directions of FIG. 13A, but not in the Z direction).

It will be understood, of course, that the faces of blade 424 can be curved in any of a variety of ways, such as having a single, uniform radius of curvature (i.e., a surface that follows a portion of a circular path). ), a radius of curvature that varies constantly along its entire length (or a part of it), or segments of curved shapes and / or variable curvature that include one or more segments that are flat both through across its width as well as its length. However, the direction of curvature of each of the six faces does not change along their respective lengths, and the curvature axes of each of the pairs of opposite faces (for example, the first face (428) and the fourth face (434)) are parallel to each other and are perpendicular to a plane that includes the longitudinal axis (L) of the waveguide. In addition, the cross-sectional shape of the blade 424 through any portion of the blade distal to the transition segments is an equiangular hexagon.

It will also be seen from FIG. 14 that although the cylindrical portion (425) extends distally away from the most distal taper (418C) of the waveguide (located at the most distal node of the waveguide), an increasing distal taper is also provided (427) between the cylindrical part (425) and the transition segments (A) of the faces of the blade.

FIG. 15 depicts yet another alternate embodiment of a blade (524) having six faces (528 538) that intersect at an included angle of approximately 120 degrees. In this case, because the radius of curvature of the distal segment 528C of the first face 528 is small enough (that is, more curvature), the first face 528 ends before the distal end of the insert. work from which it was manufactured. As a result, the first face (528) and, in part, the second and sixth faces (530, 538), terminate in the cylindrical face (527), which is a remnant of the distal cylinder (eg, 42A in FIGS. 9A-9E) created by turning the original round billet. Therefore, in the embodiment shown in FIG. 15, while the curved portion of the blade (524) once again has six faces arranged as three pairs of opposing faces, the cross-sectional shape of the blade in any plane perpendicular to the longitudinal axis of the waveguide through of the curved part of the blade is a hexagon except through the most proximal parts of the transition segments and except through the cylindrical face (527).

FIGS. 21-25 depict another alternate embodiment of a blade (824) having six faces (828-838) that intersect at an included angle of approximately 120 degrees. These faces extend distally away from the cylindrical portion (825) toward the distal tip (826). As in previous embodiments, each face is flat across its width and curves in a single direction along its length. The six faces are arranged in three pairs, such that the cross-sectional shape of the blade in any plane perpendicular to the longitudinal axis of the waveguide through the curved part of the blade (except through some segments transition, as described herein) is a hexagon. Furthermore, the opposite faces of each pair are parallel across their widths, and they curve in the same direction. However, one face of a pair has a positive curvature (a concave surface) while the other face has a negative curvature (a convex surface). Furthermore, all the axes of curvature of the six faces of the blade are perpendicular to a plane that includes the longitudinal axis (L) of the waveguide. However, given the hexagonal cross section of the blade, there are three such planes (one for each pair of opposing faces). Therefore, the included angle between the adjacent faces is a constant of 120 degrees along the length of the curved part of the blade. The intersection of each pair of adjacent faces of the curved portion of the blade defines a cutting edge for use during surgical procedures.

All six faces of the blade 824 have an elliptical curvature, with the ellipses defining the curvature sloping. For convexly curved faces, a concavely curved transition segment is again included to provide a smooth transition from the cylindrical billet. The curvature of each of these transition segments follows a part of a circle, as seen in FIGS. 21 and 23. In the three adjacent, concavely curved faces (828, 830, 838), a separate and distinct transition segment is not included, since the concave transitions of the cylindrical part (825) are incorporated into the face curved concave.

With reference to FIGS. 21-25, where each successive view is rotated counterclockwise (as viewed from the distal end of the blade), three of the faces (832, 834, 836) include a curved transition segment of concave shape (832A, 834A, 836A) and a distal part of the face is elliptically curved. These transition segments provide a smooth transition from the cylindrical part to the convexly curved faces (832, 834, 836). The concavely curved faces (828, 830, 838) do not have transition segments. As before, each of the transition segments on the curved blade faces is flat across its width and curves in a single direction along its length. Likewise, each distal segment of the blade faces is flat across its width and curves (in a single direction) along its length.

In the embodiment of FIGS. 21-25, the first face (828), the second face (830) and the sixth face (838) curve continuously along their entire length, having a positive elliptical curvature (i.e., curved from concave shape). Therefore, the first, second, and sixth faces of blade 824 do not have separate and distinct transition segments. As shown in FIG. 21, along its length, the curvature of the first face (828) follows a part of an ellipse (D8A) that is inclined with respect to the longitudinal axis of the waveguide. Therefore, as seen in FIG. 21, the major axis (E8A) of the ellipse (D8A) is not parallel to the longitudinal axis (L9), but is inclined with an included angle of approximately 5 degrees. Of course, the elliptical path of the first face (848) does not have to be inclined with respect to the longitudinal axis (L8) or it can be inclined by various degrees (for example, up to about 20 degrees, or between about 2 and about 10 degrees). Since the first face (828) curves continuously along this elliptical path for its entire length, the first face (828) does not include a separate and distinct transition segment.

The second face (830) and the sixth face (838) of the blade (824) are elliptically curved in a similar way, although not necessarily following elliptical curves identical to the ellipse (D8A) (for example, they can be inclined or not tilt, have different eccentricities and / or different radii). In the particular embodiment shown, the curvature of the second face (830) follows a part of an ellipse (D8C) that has a somewhat greater eccentricity than ellipse D8A. The ellipse (D8C) is tilted once more with respect to the longitudinal axis of the waveguide, as seen in FIG.

22. In this case, the major axis (E8C) of the ellipse (D8C) is inclined with an included angle of approximately 2.5 degrees with respect to the longitudinal axis of the waveguide. Again, it is not necessary to tilt the second face elliptical path 830, but it can be tilted by various degrees (eg, up to about 20 degrees, or between about 2 to about 10 degrees). Although the elliptical path of the curvature of the sixth face (838) is not shown in FIG. 25, the curvature of the sixth face (838) follows a part of an inclined ellipse that is similar to the ellipse (D8C) shown in FIG. 22 (eg, inclined by about 2.5 degrees, or alternatively up to about 20 degrees, or between about 2 and about 10 degrees).

The convexly curved distal portions (or segments) of the opposite faces (i.e., the third face (832) in opposite relation to the sixth face (838), the fourth face (834) in opposite relation to the first face ( 828), and the fifth face (836) in opposite relation to the second face (830)) are also elliptically curved in a similar manner. These opposite faces also have transition segments (A) (eg, transition segment (832A) of third face (832)) that curve concavely, as described hereinbefore. In this particular embodiment, the transition segments (832A, 834Am 836A) are flat across their width and curve in a single direction along the length of that face. In the embodiment shown, the curvature of these transition segments (832A, 834A, 836A) follows a part of a circle (G8) (see FIGS.

21 and 22). However, once again, the axis of curvature of the transition segments (that is, the center of the circle (G8)) is parallel to the axis of curvature of the associated face, and is perpendicular to a plane that includes the longitudinal axis (L) of the waveguide. Transition segments can be curved along a part of a similar circle (G8), or different sized circles can be used for one or more of the transition segments.

The opposing convexly curved distal segments of the third face (832) (in opposite relation to the sixth face (838)), the fourth face (834) (in opposite relation to the first face (828)), and the fifth face 836 (in opposite relation to second face 830) follow parts of inclined ellipses similar to their opposite concave faces. Therefore, each pair of opposing faces is curved along its lengths in the same singular direction, with one face of each pair curved concavely along its entire length, and the other face having the opposite of each pair a convexly curved distal segment and a concavely curved transition segment.

In the specific embodiment shown, the elliptical curvature of the distal segment of the fourth face (834) is not only negative (that is, it is convex), but it follows a part of an ellipse (D8B) which, like the ellipse (D8A), is inclined with respect to the longitudinal axis (L) of the waveguide. In fact, although they are merely exemplary of one embodiment, ellipses D8A and D8B are concentric (that is, they have a central point and common major and minor axes) and have the same eccentricity. As a result, the distance between the elliptically curved portions of the first and fourth faces (828, 834) is constant along the length of the blade.

The elliptical curvature of the distal segment of the fifth face (836) is also negative (that is, it is convex), following a part of an ellipse (D8D) that is not only inclined to the same extent as the ellipse (D8C), but which is also concentric with the D8C (that is, the D8C and D8D ellipses have a common center point and major and minor axes). However, the eccentricity of the ellipse (D8D) is less than that of the ellipse (D8C). As a result, the second face (830) has a slightly less curvature than the fifth face (836) (that is, it is somewhat flatter), and therefore the distance between the second face (830) and the fifth face (836 ) tapers along their lengths such that the blade (824) is slightly tapered. Although the elliptical path of the curvature of the sixth face (832) is not shown in FIG. 25, the curvature of the sixth face (832) follows a part of an inclined ellipse that is similar to the ellipse (D8D) shown in FIG. 22 (eg, inclined by about 2.5 degrees, or alternatively up to about 20 degrees, or between about 2 and about 10 degrees). Therefore, the distance between the third face (832) and the sixth face (838) similarly decreases along their lengths, as long as the blade (824) has additional taper along its length.

In addition, the blade (824) is also symmetrical with respect to a plane that includes the longitudinal axis (L) of the waveguide (that is, a plane parallel to the plane of FIG. 21 that includes the longitudinal axis (L) Because of this, as well as the curvature of the blade, the blade will vibrate both longitudinally and transversely (ie, in the X and Y directions of FIG. 13A, but not in the Z direction).

It will be understood, of course, that the faces of the blade 824 can be curved in any of a variety of ways, such as having a single, uniform radius of curvature (i.e., a surface that follows a portion of a circular path). ), a radius of curvature that varies constantly along its entire length (or a part of it), or segments of curved shapes and / or variable curvature that include one or more segments that are flat both through across its width as well as its length. However, the direction of curvature of each of the six faces does not change along their respective lengths, and the curvature axes of each of the pairs of opposite faces (for example, the first face (828) and the fourth face (834)) are parallel to each other and are perpendicular to a plane that includes the longitudinal axis (L) of the waveguide. Furthermore, the cross-sectional shape of the blade (824) through any portion of the blade distal to the transition segments is an equiangular hexagon.

Although various embodiments of ultrasound surgical devices and blades thereof have been described in detail above, it will be understood that the components, features and configurations, as well as the methods of manufacturing the devices and the methods described herein they are not limited to the specific embodiments described herein.

Claims (24)

1. An ultrasound surgical device (10, 110) comprising: an elongated waveguide (12, 112) having a longitudinal axis (L, L8, L9) and a distal end; the ultrasound surgical device (10) further comprising: a blade (24, 124, 224, 324, 424, 524, 624, 824) extending away from the distal end of the waveguide (12, 112), said blade (24, 124, 224, 324, 424) having , 524, 624, 824) a length, a distal end, and a curved portion that includes at least five faces extending longitudinally along at least a portion of the length of the blade (24, 124, 224, 324, 424, 524, 624, 824), each of said faces having a width extending perpendicular to the longitudinal axis (L, L8, L9) of the waveguide (12, 112) and a length extending from shape orthogonal to said width, wherein each of the faces is flat across its width and is either flat along its entire length or includes one or more curved segments (28A, 28C, 34A, 34C) along its length. length, each of the curved segments (28A, 28C, 34A, 34C) of an individual face curved in the same direction being curved in such a way that the curvature axes of each of the curved segments (28A, 28C, 34A , 34C) of an individual face are parallel to each other, and the axis of curvature of each of the curved segments (28A, 28C, 34A, 34C) of the blade faces (24, 124, 224, 324, 424, 524, 624, 824) is perpendicular to a plane that includes the longitudinal axis (L, L8, L9) of the waveguide (12, 112); and furthermore wherein at least one of the faces of the blade (24, 124, 224, 324, 424, 524, 624, 824) includes one of said curved segments (28A, 28C, 34A, 34C). The ultrasound surgical device (10, 110) of claim 1, wherein the intersection of each pair of adjacent faces defines a cutting edge that extends along at least a portion of the length of the blade (24 , 124, 224, 324, 424, 524, 624, 824), and the included angle between adjacent faces is between 100 and 140 degrees. The ultrasound surgical device of claim 1 or 2, wherein said blade (24, 124, 224, 324, 424, 524, 624, 824) has at least six of said faces. The ultrasound surgical device (10, 110) of any one of claims 1-3, wherein said blade (24, 124, 224, 324, 424, 524, 624, 824) has six faces arranged as three pairs opposite faces, where the included angle between adjacent faces is approximately 120 degrees, such that the cross-sectional shape of the curved portion of the blade (24, 124, 224, 324, 424, 524, 624, 824 ) in a plane perpendicular to the longitudinal axis (L, L8, L9) of the waveguide (12, 112) is an equiangular hexagon. The ultrasound surgical device (10, 110) of any one of claims 1-4, wherein each of said blade faces (24, 124, 224, 324, 424, 524, 624, 824) includes a transition segment (A) curved at its proximal end. The ultrasound surgical device (10, 110) of any one of claims 1-5, wherein at least one of said faces has a convexly curved distal segment extending to the distal end of the face, and another of said faces has a concavely curved distal segment that extends to the distal end of the face. 7. The ultrasound surgical device (10, 110) of any one of claims 1-6, wherein one or more of said faces is curved along its entire length. The ultrasound surgical device (10, 110) of claim 1, wherein said blade (24, 124, 224, 324, 424, 524, 624, 824) has six faces arranged in three pairs of opposite faces, in wherein at least one of said faces has a convexly curved distal segment that extends to the distal end of the faces, and the opposite face has a concavely curved distal segment that extends to the distal end of the face. The ultrasound surgical device (10, 110) of claim 8, wherein the curvature of said convexly curved distal segment is equal to or less than the curvature of the concavely curved distal segment of the opposite face. The ultrasound surgical device (10, 110) of claim 9, wherein the curvature of the radius of said convexly curved distal segment is greater than the curvature of the concavely curved distal segment of the opposite face, such such that a distal portion of the blade (24, 124, 224, 324, 424, 524, 624, 824) tapers in the distal direction. The ultrasound surgical device (10, 110) of claim 1, wherein each of said faces has a concavely curved transition segment (832A, 834A, 836A) at its proximal end, a middle segment (B ) flat and a distal segment extending to the distal end of the face, at least one of said distal segments having a convex curvature and another of said distal segments having a concave curvature. 12. The ultrasound surgical device (10, 110) of claim 1, wherein: - said blade (24, 124, 224, 324, 424, 524, 624, 824) has six faces arranged in three pairs of opposite faces; - the included angle between adjacent faces is approximately 120 degrees, such that the cross-sectional shape of the blade (24, 124, 224, 324, 424, 524, 624, 824) in any plane extending to Through the six mentioned faces and perpendicular to the longitudinal axis (L, L8, L9) of the waveguide (12, 112), it is an equiangular hexagon; - the opposite faces of each pair are parallel across their widths, and curve in the same direction; Y - a distal part of one face of each pair has a positive curvature while the opposite distal part of the other face of that pair has a negative curvature. The ultrasound surgical device (10, 110) of claim 12, wherein at least the distal portion of all six faces has an elliptical curvature. The ultrasound surgical device (10, 110) of claim 13, wherein the ellipses defining said elliptical curvatures are inclined with respect to the longitudinal axis (L, L8, L9) of the waveguide (12, 112) . 15. The ultrasound surgical device (10, 110) of claim 1, wherein: - said blade (24, 124, 224, 324, 424, 524, 624, 824) has six faces arranged in three pairs of opposite faces; - three of said faces located adjacent to each other and defining an edge between them are positively curved along the entire length of the face; - the other three faces located adjacent to each other and defining an edge between them are negatively curved along the length of a distal part of the face, and positively curved along the length of a proximal part of the face. 16. The ultrasound surgical device (10, 110) of claim 1, wherein one or more of said faces includes a curved segment having an elliptical curvature. 17. The ultrasound surgical device (10, 110) of claim 16, wherein the ellipse that defines that elliptical curvature is inclined with respect to the longitudinal axis (L, L8, L9) of the waveguide (12, 112) . The ultrasound surgical device (10, 110) of claim 1, wherein the intersection of each pair of adjacent faces defines a cutting edge that extends along at least a portion of the length of the blade (24 , 124, 224, 324, 424, 524, 624, 824), wherein at least one of said cutting edges curves in two directions along the length thereof. The ultrasound surgical device (10, 110) of claim 18, wherein the intersection of each pair of adjacent faces defines a curved cutting edge, wherein each of said cutting edges curves in two directions along the length of it. 20. The ultrasound surgical device (10, 110) of claim 1, wherein at least one of the included angles between adjacent faces is greater than 20 degrees, less than at least one of the other included angles along at least a part of the blade (24, 124, 224, 324, 424, 524, 624, 824). 21. The ultrasound surgical device (10, 110) of claim 1, further comprising a jaw member having a curved tissue-engaging surface, said pivotable jaw member supported adjacent the blade (24, 124 , 224, 324, 424, 524, 624, 824), wherein said tissue engaging surface has a curvature that corresponds to the curvature of at least a part of one of the faces of the blade (24, 124, 224, 324, 424, 524, 624, 824), and wherein furthermore the jaw element can selectively pivot between an open position where the jaw element separates away from the blade (24, 124, 224, 324, 424 , 524, 624, 824) and a closed position where the jaw element can push the tissue against said one of the faces of the blade (24, 124, 224, 324, 424, 524, 624, 824). 22. A method of manufacturing the ultrasound surgical device of any one of claims 1-21 from a round billet segment without milling in the Z axis, comprising the step of milling said round billet segment using a milling cutter. finished to produce each of said faces of said blade (24, 124, 224, 324, 424, 524, 624, 824). 23. An ultrasound surgical device, comprising a blade (24, 124, 224, 324, 424, 524, 624, 824), said blade having (24, 124, 224, 324, 424, 524, 624, 824) a length, a distal end, and a curved portion comprising six longitudinally extending faces along at least a portion of the length of the blade (24, 124, 224, 324, 424, 524, 624, 824), each of said faces having a width, a length that extends orthogonal to the width of the face, and a distal segment that extends to the distal end of the blade (24, 124, 224, 324, 424, 524, 624 , 824), where: - each of the faces is flat across its width and, along its entire length, is flat or curved along one or more curved segments (28A, 28C, 34A, 34C), each of the curved segments (28A, 28C, 34A, 34C) being curved on an individual face in the same direction such that the axes curvature of each of the curved segments (28A, 28C, 34A, 34C) of an individual face are parallel to each other and no face bends in more than one direction; - the faces are arranged as three pairs of opposite faces in such a way that the opposite faces of each pair are parallel across their width, and the curvature axes of each of the curved segments (28A, 28C, 34A, 34C) of the opposite faces of each pair are parallel to each other; Y - at least one of said distal segments has a convex curvature along its length and the distal segment of the opposite face of said at least one convex distal segment (34C) has a concave curvature along its length. 24. The ultrasound surgical device of claim 23, wherein each of said distal segments is curved such that the distal segment of one face of each of said pairs has a convex curvature and the distal segment of the other face of that pair has a concave curvature.